Institutional Registry of Liver Transplantation (IRLT)

July 18, 2016 updated by: Liliana Paloma Rojas Saunero, Hospital El Cruce

The Institutional Registry of Liver Transplantation is a system for data collection related to patients with liver disease who are possible candidates for liver transplantion. This tool was designed by a multidisciplinary team that includes hepatologists, surgeons, informatics and biostatisticians. It intends to collect the information from the clinical evaluation, physical examination, complementary diagnostic methods and laboratory data. The information is captured sistematically, following structured, standardized and monitored processess to ensure the quality of the data obtained.

The aim is to use the available technology to generate a complete database that can be used to answer research questions.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • Buenos Aires
      • Provincia Florencio Varela, Buenos Aires, Argentina, B1888AAE
        • Recruiting
        • Hospital de Alta Complejidad El Cruce
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic liver disease or acute liver failure who are candidates for liver transplantation.

Description

Inclusion Criteria:

  • Patients with indication for liver transplantation
  • Patients who are followed by the Liver Transplantation Unit of Hospital El Cruce

Exclusion Criteria:

  • Patients who deny to participate after the informed consent process.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to mortality
Time Frame: 5 years

All patients are followed from the date of the inclusion to the registry, by periodic controls by the hepatologists and through telephones calls by the coordinator nurse, both before and after the transplantation.

Every patient who dies during the 5 years of follow up will count as an event. Patients who are lost to follow up will be censored, in this case we will use the date of the last control or telephone call where he or she was alive.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to retransplantation
Time Frame: 5 years
We will considerate retransplantation as a competitive risk for death, calculating the time since the date of the transplant until the date of retransplantantion or not during the 5 years of follow up.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital El Cruce

Investigators

  • Principal Investigator: Liliana P Rojas Saunero, MD, Hospital El Cruce

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Anticipated)

July 1, 2018

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

July 15, 2016

First Submitted That Met QC Criteria

July 18, 2016

First Posted (Estimate)

July 21, 2016

Study Record Updates

Last Update Posted (Estimate)

July 21, 2016

Last Update Submitted That Met QC Criteria

July 18, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 120716/1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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